A Novel Vascular Closure Device for Heart Transplant Patients

Abstract

Cardiac allograft vasculopathy (CAV) is the leading cause of morbidity and mortality in heart transplant recipients. Despite advancements in immunosuppression with calcineurin inhibition, CAV remains a significant issue for patients and physicians. Annual coronary angiography has become the gold standard for the assessment of CAV. The current recommendations are for annual angiography for cardiac transplant recipients. This results in repeated percutaneous access to the femoral artery, which can result in complications and scar tissue formation. The Vascade Vascular Closure System appears to be a useful addition to the collection of vascular closure devices, particularly in patients who are expected to undergo repeated coronary angiograms such as cardiac transplant recipients. Its design allows for a potentially lower incidence of tract fibrosis and scar tissue formation. 

Introduction

End-stage heart failure is a significant cause of morbidity and mortality, and cardiac transplant is the definitive therapy in carefully selected patients, offering excellent long-term survival. Annually, over 5000 heart transplants are performed in the United States, with the current median survival estimated to be more than 10 years.¹ In the early days of heart transplant, survival was lower, with many patients dying within the first year. The cause of mortality was multifactorial, including infection, rejection, and cardiac allograft vasculopathy (CAV).² 

Calcineurin inhibition, initially with cyclosporine in 1987 and now with tacrolimus (FK-506), has had a major impact in reducing the incidence and morbidity of rejection.³ In addition, medium-term life expectancy has been dramatically increased with the use of these medications.⁴ Frequent right heart biopsies have allowed for early detection of transplant rejection, which enables the use of tailored immunosuppressive therapy for treatment, thereby improving outcomes. Despite these advances in immune-modulation therapy resulting in reduced mortality due to organ rejection, CAV remains a major source of morbidity and is the leading cause of mortality in cardiac transplant recipients. 

CAV develops in around 30% of heart transplant recipients within the first 5 years after transplant⁵, and is characterized by diffuse thickening of epicardial and intramural arteries secondary to inflammatory cell accumulation and vascular smooth muscle proliferation⁶. Identification of patients who have significant CAV has important prognostic implications. Keogh et al showed that moderate or severe proximal or mid-vessel disease observed on routine angiography portends a 2-year mortality of more than 50%.⁷ Other studies have shown that the rapidity of development of CAV in cardiac transplants correlates with the incidence of myocardial infarction, congestive heart failure (CHF), sudden death or retransplantation.⁸ CAV amenable to revascularization portends a better prognosis than does disease that may not be thus treated.^9,10 However, studies have not consistently demonstrated an improvement in the rate of graft survival with revascularization.¹¹ Further, transplanted hearts are denervated; therefore, patients do not present with typical angina. As a result, angiography remains the gold standard for diagnosis and surveillance, and is recommended to be performed annually.¹² This can be complicated, as a significant proportion of transplant patients have ischemic cardiomyopathy and poor peripheral vasculature. This often translates into repeated coronary angiograms and femoral artery access prior to cardiac transplant.   

With the need for annual angiography after transplant, access site complications become increasingly relevant. Traditionally, the common femoral artery has been used for access during coronary artery angiograms, and manual compression has been the method for achieving hemostasis after the procedure.  Several trials have investigated the efficacy of vascular closure devices as compared to manual compression. Both the ISAR-CLOSURE trial and the CLOSE-UP study showed that vascular closure devices are non-inferior to manual compression with respect to vascular complications. In addition, the time needed to achieve hemostasis was significantly reduced, as was hematoma size if it were to occur.^13,14 Furthermore, Duffin et al showed that patients treated with an active closure device, in this case Angio-Seal (St. Jude Medical), demonstrated a reduction in time to ambulation and in length of stay. Importantly, it also resulted in improved 30-day patient satisfaction as compared to manual compression.¹⁵ These techniques, however, require the introduction of a bulky device over a wire after removal of the sheath. In fact, these devices generally have a larger diameter than the introducer sheath used in the procedure, which can lead to pain and possible damage to the arteriotomy site.   

The recently introduced Vascade Vascular Closure System (VCS) (Cardiva Medical, Inc.) (Figure 1) utilizes a small amount of resorbable collagen sponge that provides hemostasis via both mechanical and physiologic routes. The collagen patch tamponades bleeding via rapid expansion in the presence of fluid. The natural thrombogenic properties of collagen then provides physiologic hemostasis. The collagen sponge is left in the extravascular space, with nothing left in the intravascular space. Because of the relatively low mass of the Vascade collagen and its sponge-like characteristic, its implantation in the extravascular space may have minimal impact on formation of scar tissue. In addition, as opposed to other vascular closure devices, the Vascade VCS is placed within the pre-existing 5, 6, or 7 French (F) introducer sheath, thereby obviating the need to remove the sheath and place a new closure device over a wire (Figure 1). Other systems routinely involve the introduction of the device over a wire, which can cause significant pain and further complications. Placing the Vascade VCS within the sheath eliminates this risk. In a multicenter, randomized, prospective trial, RESPECT, Vascade was evaluated against manual compression (MC).  The trial involved 420 patients in a 2:1 ratio (Vascade vs MC). Vascade demonstrated rapid hemostasis and ambulation, and low complication rates. There were zero major complications and a 1.1% incidence of minor complications, demonstrating a statistically significant reduction in complication rate as compared to manual compression.¹⁶ No head-to-head trials have been conducted comparing different vascular closure devices. Therefore, many operator preferences remain anecdotal and tailored to their specific patients.     

The appeal of an extravascular closure device such as Vascade is that it avoids compromising the arterial lumen, as there are no remnants left in the artery. Also, the resorbable extravascular collagen sponge of Vascade can eliminate some of the common issues with recurrent vascular access such as tract fibrosis. This makes the Vascade VCS particularly useful in patients who are expected to undergo repeated coronary artery angiography, such as cardiac transplant recipients. In addition, the improved time needed for a patient to recover and ambulate also improves patient satisfaction, which can be especially important in cardiac transplant recipients who have already spent a significant amount of time in hospital settings.

References

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This article received a double-blind review from members of the Cath Lab Digest Editorial Board.

Disclosure: The authors report no conflicts of interest regarding the content herein.

Neel Khanna, MD, MPH, can be contacted at nk11283@gmail.com.